Data / Medical devices / United States / Total Quality Medical, Inc.
Total Quality Medical, Inc.: FDA-registered device maker in Kennebunk, ME, United States, 1 510(k) clearance
Total Quality Medical, Inc. is registered with the FDA (registration 3014144799) in Kennebunk, ME, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 2, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014144799
- Address
- 128 York ST, Kennebunk, ME, United States, 04043
- Owner or operator
- Total Quality Medical Inc. (10056321)
- Roles
- Repackager or relabeler
- First device listed
- November 28, 2017
- Registered through
- 2026
- Brand names listed
- TQE Plus Endotoxin 10" Filter Flat 222 Head, TQE Plus Endotoxin 20" Filter Flat 222 Head, TQE Plus Endotoxin 30" Filter Flat 222 Head
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Subsystem, Water Purification | FIP | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 2, 2017 | K161304 | EndoPur Filter | FIP | Substantially Equivalent | Nephros, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 2, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.